BEUDAMED
    FDA Recall Terminated

    Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106

    Recall: Z-0645-2016 · Initiated November 18, 2015

    Recall

    Recall Number
    Z-0645-2016
    Event Number
    72698
    Firm
    Cyberonics, Inc
    FEI Number
    1000117004
    Product Code
    LYJ
    Status
    Terminated
    Root Cause
    Manufacturing material removal
    Initiated
    November 18, 2015
    Posted
    January 13, 2016
    Terminated
    September 6, 2017
    Address
    100 Cyberonics Blvd, Houston, TX, 77058-2069

    Description

    Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106

    Reason

    Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery longevity.

    Action

    Cyberonics sent out written recall notification beginning October 14, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For further questions, please call 866-882-8804

    Distribution

    US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.

    Quantity

    29 units